N4 Pharma PLC Update on Sildenafil clinical plans (2088M)
July 27 2017 - 1:00AM
UK Regulatory
TIDMN4P
RNS Number : 2088M
N4 Pharma PLC
27 July 2017
27 July 2017
N4 Pharma Plc
("N4 Pharma" or the "Company")
Update on Sildenafil clinical plans
N4 Pharma Plc (AIM: N4P), a specialist pharmaceutical company
which reformulates existing drugs and vaccines to improve their
performance, is pleased to announce the appointment of Bio-Images
Drug Delivery Limited ("BDD") to undertake a pilot clinical trial
("Pilot Trial") in a limited number of healthy male volunteers to
obtain preliminary data on two potential reformulations of
Sildenafil in line with the Company's patent applications.
BDD operate a phase 1 clinical trials unit based in Glasgow
Royal Infirmary and are specialists in conducting clinical studies
for investigational medicinal products.
The Pilot Trial is due to take place in early 2018 with results
expected by the end of April 2018.
Assuming a positive outcome from the Pilot Trial, the Company
would then use the resulting data as the basis to determine the
full requirements for a pivotal Clinical Study ("Clinical Study").
This Clinical Study, together with the data from the Pilot Trial,
would form the basis of the Company's dialogue with the Food and
Drug Administration and relevant European regulatory authorities
prior to seeking to commercialise our product with the right
licensing partner. The Clinical Study could take from 12 to 18
months and would form the basis for a marketing authorisation
submission.
Nigel Theobald, CEO of N4 Pharma, commented:
"BDD are an ideal partner to perform our pilot clinical trials.
They provide us with the opportunity to test a range of potential
reformulations to establish which best delivers our target product
profile.
"The erectile dysfunction market had global annual sales of
approximately $4.6 billion in 2016. A faster acting, longer lasting
version of Sildenafil has the ability to be a major new product in
the erectile dysfunction market."
Enquiries:
N4 Pharma Via Alma PR
CEO, Nigel Theobald
Stockdale Securities Tel: +44(0)207 601
Tom Griffiths 6100
Beaufort Securities Tel: +44(0)207 382
Elliot Hance 8300
Alma PR Tel: +44(0)778 090
Josh Royston 1979
Robyn Fisher Tel: +44(0)754 070
6191
About N4 Pharma
N4 Pharma was formed in 2014 by Nigel Theobald, the former Chief
Executive of AIM quoted Oxford Pharmascience Group plc. It is a
specialist pharmaceutical company which reformulates existing drugs
and vaccines to improve their performance.
N4 Pharma's reformulation work falls under two divisions:
-- generic, already commercialised, drugs; and
-- delivery of novel and existing vaccines.
N4 Pharma has identified a number of established drugs that
could be improved upon through its reformulation techniques. N4
Pharma's most advanced reformulation is for sildenafil, widely
marketed as Viagra, where N4 Pharma is seeking to improve the speed
at which the drug takes effect whilst also extending its duration
of action.
N4 Pharma's reformulation approach should take approximately
three years to obtain regulatory approval as opposed to the
traditional process for new drugs of on average ten years. The cost
and risk profile of this model is also significantly less than the
traditional process. N4 Pharma's business model is to take
reformulated drugs from its portfolio through to the stage where it
will license its newly reformulated drugs to pharmaceutical
companies to commercialise them. N4 Pharma's revenues should be
derived from up front milestone and royalty payments associated
with the licence.
About BDD
BDD is a specialist drug delivery company with expertise in
modified drug release and gamma scintigraphy. BDD Scintigraphy is a
powerful, fast and incredibly effective tool that can be coupled
with pharmacokinetics to provide a clear picture of formulation
behaviour in man. The data generated from a scintigraphic clinical
study can provide information on site and time of disintegration of
tablets, Gastro Intestinal transit and the effects of food and
regional absorption. Data from scintigraphic studies can be used to
validate product claims, guide development strategies, provide
valuable marketing data and provide information on regional
absorption.
This information is provided by RNS
The company news service from the London Stock Exchange
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